Effect of Clips Versus Omentopexy on Postoperative Bleeding

NCT06211699 | Completed

• 1 other identifier: 218494864
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective randomized study, patients were divided into two groups: clips group and omentopexy group. The groups were compared in terms of postoperative decrease in hemoglobin and hematocrit values, preoperative and peroperative blood pressure values, duration of surgery, number of patients requiring erythrocyte suspension (ES) transfusion, length of hospital stay, hospital readmissions in the first 30-days postoperatively and early postoperative complications.

Conditions

Bleeding; Postoperative Complications; Postoperative Nausea and Vomiting

Keywords

Laparoscopic Sleeve Gastrectomy; Bleeding; Staple Line Reinforcement; Postoperative First Month Readmission

Outcome Measures

Primary Outcomes (1)

• Postoperative Bleeding

  The primary outcome of the study was to compare the two methods in terms of early postoperative bleeding. This comparison will be made with hemoglobin and hematocrit values measured at postoperative 6th hour, 24th hour and at discharge. The groups will be compared according to the decrease in hemoglobin and hematocrit values, whether ES displacement is required, and whether intervention is required.

  up to 3 Months

Secondary Outcomes (2)

• Postoperative First Month Readmission

  30-days postoperatively

• The duration of surgery (minutes)

  Intraoperative

Study Arms (2)

Omentopexy with Laparoscopic Sleeve Gastrectomy

ACTIVE COMPARATOR

Patients who underwent continuous through-and-through omentopexy of the omentum to the remnant stomach staple line after resection during Laparoscopic Sleeve Gastrectomy (omentopexy group).

Procedure: Omentopexy with Laparoscopic Sleeve Gastrectomy

Clips with Laparoscopic Sleeve Gastrectomy

ACTIVE COMPARATOR

Patients who underwent consecutive clippping along the staple line of the remnant stomach during Laparoscopic Sleeve Gastrectomy (clips group)

Procedure: Clips with Laparoscopic Sleeve Gastrectomy

Interventions

Omentopexy with Laparoscopic Sleeve Gastrectomy PROCEDURE

Patients with omentum sewed to the remnant gastric staple line during laparoscopic sleeve gastrectomy.

Omentopexy with Laparoscopic Sleeve Gastrectomy

Clips with Laparoscopic Sleeve Gastrectomy PROCEDURE

Patients performed clips to the remnant gastric staple line during laparoscopic sleeve gastrectomy

Clips with Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Patients who underwent LSG
• Between the ages of 18 and 65,
• A Body Mass Index (BMI) ≥ 40 or BMI ≥ 35 with at least one obesity-related comorbidity

You may not qualify if:

• Patients who underwent other bariatric surgery procedures,
• Patients who declined to be participate
• uncontrolled hypertension
• preoperative history of gastroesophageal reflux disease (GERD) symptoms

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, Umraniye, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemorrhage; Postoperative Complications; Postoperative Nausea and Vomiting

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Muhammed Taha Demirpolat, M.D.

  Umraniye Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The primary surgeon is naturally not blinded to the patient groups and the other surgeon who records and evaluates the data is blinded to the patient groups. The patient was blind to the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof., FEBS-MIS

Model Details: Prospective Randomized Controlled Trial

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 18, 2024
• Study Start: July 1, 2023
• Primary Completion: November 25, 2023
• Study Completion: December 25, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)